CompletedNot Applicable

Prevention of Colorectal Cancer Through Multiomics Blood Testing

United States48,995 participantsStarted 2020-05-20

Plain-language summary

The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Who can participate

Age range45 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 45-85 years of age
✓. Willing to undergo a standard-of-care screening colonoscopy
✓. Able and willing to provide a blood sample
✓. Able and willing to sign informed consent

Exclusion criteria

✕. Known hereditary gastrointestinal cancer syndrome (for example, hereditary non-polyposis CRC syndrome (HNPCC) or Lynch syndrome, or familial adenomatous polyposis (FAP)
✕. Personal history 2.1 CRC or colorectal adenoma 2.2 Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and crohn's disease (CD) 2.3 Colonoscopy in the 9 years preceding enrollment 2.4 Stool DNA testing in the 2 years preceding enrollment 2.5 Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation
✕. A medical condition which, in the opinion of the Investigator, should preclude enrollment in the study
✕. Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy

What they're measuring

Sensitivity for Colorectal Cancer

Timeframe: 90 days

Specificity for Advanced Colorectal Neoplasia

Timeframe: 90 days

Negative Predictive Value for Advanced Colorectal Neoplasia

Timeframe: 90 days

Positive Predictive Value for Advanced Colorectal Neoplasia

Timeframe: 90 days

Trial details

NCT IDNCT04369053

SponsorFreenome Holdings Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-02-29

Results submitted2025-11-06

View on ClinicalTrials.gov More Colon Cancer trials

Who can participate

Age range45 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 45-85 years of age
✓. Willing to undergo a standard-of-care screening colonoscopy
✓. Able and willing to provide a blood sample
✓. Able and willing to sign informed consent

Exclusion criteria

✕. Known hereditary gastrointestinal cancer syndrome (for example, hereditary non-polyposis CRC syndrome (HNPCC) or Lynch syndrome, or familial adenomatous polyposis (FAP)
✕. Personal history 2.1 CRC or colorectal adenoma 2.2 Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and crohn's disease (CD) 2.3 Colonoscopy in the 9 years preceding enrollment 2.4 Stool DNA testing in the 2 years preceding enrollment 2.5 Symptoms of lower gastrointestinal tract disease warranting colonoscopic evaluation
✕. A medical condition which, in the opinion of the Investigator, should preclude enrollment in the study
✕. Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 60 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy